NCT06444841 · RECRUITING

Paper-Based and Smartphone-Based Memory Supports

This trial compares two memory aids for people with mild cognitive impairment or early dementia: a smartphone reminder app versus a structured paper planner. Researchers want to know which helps people remember planned tasks better, and whether benefits last up to six months. It is a Phase NA randomized controlled trial — meaning it is testing real-world effectiveness of behavioral tools, not a drug. About 200 participants will be enrolled, including people from rural and underserved communities.

Eligibility criteria

Inclusion Criteria:
* Demonstrate capacity to consent via structured interview that involves reviewing core study features and probing for understanding of potential benefits/consequences of participating, and understanding that one can withdraw consent at any point, or availability to obtain surrogate consent.
* Clinical features consistent with a diagnosis of MCI or dementia. For clinic-referred participants, available records will be reviewed to ensure the clinical diagnosis meets published diagnostic guidelines. If there is not sufficient documentation for diagnostic purposes, then semi-structured clinical interview and cognitive screening (see below) will be reviewed by clinical staff.
* Cognitive status for inclusion will be assessed by Montreal Cognitive Assessment (MoCA) scores of 17-25 (or 12-18 for the telephone version if in-clinic assessment is not feasible). While some studies suggested that these ranges are appropriate across diverse groups, recent work indicates that adjustment of 1-2 points for different demographics improves instrument sensitivity in disadvantaged groups. The latter approach will be taken.
* Functional status will be assessed via semi-structured interview with the Global Deterioration Scale (GDS), with stage 3 or 4 indicating independence in basic self-maintenance activities.
* Adequate sensory and motor abilities to utilize a smartphone with accommodation.
* Availability of a co-participant who sees the participant at least once a month.
Co-Participant Inclusion Criteria:
* The co-participant will need to be over the age of 18, consent to participation, and see the participant at least once per month.
Exclusion Criteria:
* History of serious mental illness including schizophrenia or bipolar disorder that is judged by the clinician to be the primary cause of cognitive decline.
* Indication of moderate or severe dementia based on clinical documentation, MoCA score, and/or collateral/informant activities of daily living measure during the screening process (GDS score ≥5).
* Language difficulties significant enough to interfere with the screening procedures.
* Uncorrected hearing loss, vision loss, or motor dysfunction significant enough to interfere with training.
* No study partner.
* At the current time, individuals who do not identify as conversational in English will be excluded from participation.
Co-Participant Exclusion Criteria:
* Sees participant less than once per month.
* At the current time, individuals who do not identify as conversational in English will be excluded from participation.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2024-07-09

View full record on ClinicalTrials.gov

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